OTLK

Outlook Therapeutics Discusses NORSE EIGHT Clinical Trial Results and Future Plans for ONS-5010

Dr. Jennifer Kissner reviews 12-week NORSE EIGHT trial results and discusses plans for ONS-5010's BLA resubmission.

Quiver AI Summary

Outlook Therapeutics, Inc. has announced the participation of Dr. Jennifer Kissner, Senior Vice President of Clinical Development, in a Virtual Investor segment discussing the 12-week safety and efficacy results of the NORSE EIGHT clinical trial for ONS-5010, an ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The company plans to submit a Biologics License Application (BLA) resubmission for ONS-5010 in early 2025 following the trial's results. Outlook Therapeutics received regulatory approval in the EU and UK for the first ophthalmic use of bevacizumab for wet AMD and is preparing for a commercial launch in these regions in the first half of 2025. The drug is still under investigation in the U.S. and if successful, could become the first approved ophthalmic formulation of bevacizumab for retinal indications in that market. The press release also includes forward-looking statements regarding the company's future plans and the inherent risks associated with pharmaceutical development.

Potential Positives

  • Outlook Therapeutics received regulatory approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (wet AMD).
  • Dr. Jennifer Kissner announced positive 12-week safety and efficacy results from the NORSE EIGHT clinical trial for ONS-5010, supporting the company’s planned Biologics License Application (BLA) resubmission.
  • The company plans to initiate the commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and UK in the first half of calendar 2025.
  • If approved in the United States, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, creating a significant market opportunity.

Potential Negatives

  • The press release emphasizes the company's need to submit a Biologics License Application (BLA) resubmission for ONS-5010, indicating potential previous regulatory challenges that may affect investor confidence.
  • Outlook Therapeutics is still in the investigational stage for its product in the United States, suggesting uncertainty regarding its potential market entry and approval, which could hinder commercial prospects.
  • The mention of risks associated with macroeconomic factors, including ongoing overseas conflicts and inflation, highlights external challenges that could adversely impact the company's business environment and operational effectiveness.

FAQ

What were the key findings of the NORSE EIGHT trial?

Dr. Jennifer Kissner discussed the complete 12-week safety and efficacy results for the NORSE EIGHT trial during the Virtual Investor segment.

When will the Biologics License Application for ONS-5010 be resubmitted?

The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.

What is LYTENAVA™?

LYTENAVA™ is the first ophthalmic formulation of bevacizumab, approved for treating wet age-related macular degeneration in the EU and UK.

When is the commercial launch of LYTENAVA™ expected?

The commercial launch of LYTENAVA™ in the EU and UK is expected in the first half of calendar 2025.

Is ONS-5010 currently approved in the United States?

ONS-5010/LYTENAVA™ is investigational in the U.S. and undergoing a non-inferiority study for wet AMD treatment.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.


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Full Release




Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial





Watch the “What This Means” segment here






ISELIN, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) --

Outlook Therapeutics, Inc.

(Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a

Virtual Investor “What This Means” segment

.



As part of the segment, Dr. Kissner discusses the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients and the Company’s planned Biologics License Application (BLA) resubmission of ONS-5010 in the first quarter of calendar 2025.



The Virtual Investor “What This Means” segment featuring Outlook Therapeutics is now available

here

.




About Outlook Therapeutics, Inc.



Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.




Forward-Looking Statements



This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, plans to resubmit the BLA for ONS-5010 and the timing thereof, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, Outlook Therapeutics’ commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.




Investor Inquiries:



Jenene Thomas


Chief Executive Officer


JTC Team, LLC


T: 908.824.0775



OTLK@jtcir.com






This article was originally published on Quiver News, read the full story.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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